Monitoring and maintaining an intravenous assembly without medical staff involvement for safe distancing enforcement

ABSTRACT

A method and system to monitor and autonomously configure an intravascular assembly without medical staff involvement or presence. In this solution, a robotic device is associated with an intravascular assembly, which has tubing through which fluids are delivered intravenously. Monitoring of the tubing is initiated. In response to the monitoring, an errant flow through the tubing is detected; typically, the errant flow results from one of: a kink or twist in the tubing, an air bubble in the tubing, an occlusion or clot in the tubing, and pressure variations. In response to detecting the errant flow, and in advance of an audible alarm being generated in association with the intravascular assembly, a command is then issued to the associated robotic device. The command is configured to initiate, by the robotic device, physical engagement with and mechanical manipulation of the tubing, thereby remediating the errant flow automatically.

BACKGROUND

It is common in the medical field to administer medications and otherfluids to patients by intravenous infusion. During intravenous infusion,an intravenous assembly including an infusion pump is used to administera prescribed amount of medication or fluids over a certain period oftime. Infusion products are typically delivered to the patient in aclear, see-through plastic intravenous bag and dispensed through cleartubing hooked up to a catheter attachment. While intravenous infusion isimplemented quite often, patients and medical staff can encountermultiple problems associated with components of the intravenous assemblyduring administration.

For example, infusion pump alarms can cause numerous issues for bothpatients and medical staff. Continuous alarms and delayed efforts ofmedical staff at correcting an error that triggered the alarm can causesleep deprivation in a patient, which can affect a patient's ability toheal. Further, alarms triggered from roommate infusion pumps and/or whena patient is mobile with an infusion pump can also interfere with apatient's overall care.

The monitoring of infusion pumps as well as correcting triggered alarmscan be time consuming for medical staff in a hospital. For example,depending on a nurse's schedule and workload, it can take up to thirtyminutes or more for an infusion pump's alarm to be addressed. Duringthis time, as the alarm continues to ring, intravenous tubing has agreater risk of clotting which can harm the patient.

Infusion pump alarms can be triggered for multiple reasons. For example,an alarm can be triggered when air bubbles are trapped in intravenoustubing from an intravenous bag being manually changed, occlusions occurfrom kinking or clots in the intravenous tubing, intravenous bags offluids or medications become empty, and/or a pump has a low battery.Typically, medical staff can silence the alarm manually, can unkinkkinked intravenous tubing, can manually flush intravenous tubing withsaline solution to remove a clot, can disconnect intravenous tubing fromthe patient and flush the intravenous assembly of its air bubbles, canreplace a finished intravenous bag with a new one, and/or can plug theintravenous pump into the wall outlet when a low battery is detected.However, the completion of these tasks can be delayed, time consumingand alarms will continue to ring until medical staff have finished thesetasks.

An additional problem associated with the use of an intravenous assemblyis the improper placement of sensors within components of theintravenous assembly that inaccurately detect causes of errant flow. Forexample, when sensors are located within intravenous tubing and/orcatheters, these sensors are often not sensitive enough to properlydetect air bubbles in the tubing and/or catheters due in part to thelocation of the sensors.

Therefore, it would be beneficial to provide a system and method formonitoring and maintaining an intravenous assembly autonomously withoutthe need for medical staff involvement, thereby protecting the staff byenabling safe distancing from a patient (e.g., one experiencing activeCovid-19 disease symptoms) where possible.

It would also be beneficial to provide a robotic device thatpreemptively maintains the intravenous system so that intravenous pumpalarms are not triggered. Further, it would be beneficial to provide arobotic device that includes a robotic arm that can, among other things,unkink intravenous tubing, manually palpate air bubbles out of theintravenous tubing, replace an almost empty intravenous bag, flush anobstructed intravenous tubing of a clot, and/or with ultrasoundguidance, insert new intravenous tubing and a catheter into a patient.

BRIEF SUMMARY

The present application provides a system for monitoring and maintainingan intravenous assembly autonomously without the need for medical staffinvolvement. The system includes a robotic device that correctsintravenous pump alarms as well as maintains the intravenous assembly bycorrecting or maintaining specific components of the intravenousassembly that trigger an alarm. The robotic device is capable ofmaintaining the intravenous system so that intravenous pump alarms arenot triggered.

In one embodiment, a system for monitoring and maintaining anintravenous assembly is provided. The system comprises a robotic device.The robotic device includes an optical sensor configured to detect anerrant flow in at least a component of the intravenous assembly, and apressure sensor configured to manipulate at least the component of theintravenous assembly to restore, start, stop flow, or change at leastthe component of the intravenous assembly.

In some embodiments, an intravenous tubing is provided. The intravenoustubing comprises at least one sensor configured to communicate with andprovide data to the robotic device described above. The at least onesensor is disposed at a proximal end or a distal end of the intravenoustubing.

In some embodiments, a catheter is provided. The catheter comprises atleast one sensor disposed within an interior and/or exterior of thecatheter. The at least one sensor is configured to communicate with andprovide data to the robotic device described above.

In some embodiments, an intravenous container is provided. Theintravenous container comprises an interior surface and an exteriorsurface. The interior surface and/or the exterior surface include atleast one sensor configured to communicate with and provide data to therobotic device described above.

In some embodiments, an intravenous pump is provided. The intravenouspump comprises at least one sensor configured to communicate with andprovide data to the robotic device described above.

Other features and advantages of the present disclosure will becomeapparent from the following detailed description. It should beunderstood, however, that the detailed description and the specificexamples, while indicating preferred embodiments of the disclosure, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the disclosure will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

In part, other aspects, features, benefits and advantages of theembodiments will be apparent with regard to the following description,appended claims, and accompanying drawings in which:

FIG. 1 is a perspective view of a system for monitoring and maintainingan intravenous assembly comprising a robotic device. The robotic devicehas an optical sensor configured to detect an errant flow in at least acomponent of the intravenous assembly and a pressure sensor configuredto manipulate at least the component of the intravenous assembly torestore, start, stop flow, or change at least the component of theintravenous assembly. The robotic device is depicted as a humanoid robotand the patient is shown attached to the intravenous assembly.

FIG. 2 is a perspective view of the system shown in FIG. 1 where therobotic device alternatively comprises a robotic arm attached to acomponent of the intravenous assembly.

FIG. 3 is a perspective view of the robotic device of FIG. 1.

FIG. 4 illustrates a perspective view of the robotic device of FIG. 2comprising one robotic arm.

FIG. 5 is a perspective view of the robotic device of FIG. 2alternatively comprising two arms.

FIG. 6 is a perspective view of the robotic device of FIG. 2 comprisinga robotic arm attached to a component of the intravenous assembly in theform of an intravenous pump.

FIG. 7 is a perspective view of the robotic device of FIG. 2 comprisinga robotic arm attached to an intravenous pole that holds components ofthe intravenous assembly.

FIG. 8 is a perspective view of intravenous tubing comprising at leastone sensor configured to communicate with and provide data to therobotic device. The at least one sensor is shown disposed at discreteregions such as at a proximal end and/or a distal end of the intravenoustubing.

FIG. 9 is a perspective view of the intravenous tubing of FIG. 8 wherethe at least one sensor is a network of sensors located at continuousregions within an interior or exterior wall of the intravenous tubing.

FIG. 10 is a perspective view of the robotic arm of FIG. 4 engaging theintravenous tubing to unkink the intravenous tubing. The robotic armincludes a laser sensor that forms a laser perimeter around theintravenous tubing. If a section of the intravenous tubing falls outsideof the laser perimeter, the robotic arm will be alerted and the roboticarm will unkink the intravenous tubing.

FIG. 11 is a perspective view of the robotic arms of FIG. 5 engaging theintravenous tubing to unkink the intravenous tubing.

FIG. 12 is a perspective view of the intravenous tubing of FIG. 8disposed within a sleeve. The sleeve includes sensors disposed atdiscrete regions such as at a proximal end and/or a distal end of thesleeve. The sensors are configured to communicate with and provide datato the robotic device.

FIG. 13 is a perspective view of the sleeve of FIG. 12 shown with anetwork of sensors disposed at continuous regions along an entire lengthof the sleeve.

FIG. 14 is perspective view of a catheter comprising a sensor disposedat an end of a catheter needle. The end of the catheter needle isconfigured for disposal within an entrance of a patient's blood vessel.The sensor is configured to communicate with and provide data to therobotic device.

FIG. 15 is a perspective view of the catheter of FIG. 14 where thesensor is disposed within a hub of the catheter.

FIG. 16 is a perspective view of the catheter of FIG. 14 where thecatheter includes a sensor disposed at an end of a catheter needle and asensor disposed within a hub of the catheter.

FIG. 17 is a perspective view of the catheter of FIG. 14 and the roboticarm of FIG. 4. The robotic arm is shown engaging the catheter to removethe old catheter so that a new catheter can be inserted into a patient.

FIG. 18 is a perspective view of the catheter of FIG. 14 and the roboticarm of FIG. 4. The robotic arm is shown engaging a new catheter so thatthe new catheter can be inserted into a patient.

FIG. 19 is a front view of an intravenous container. The intravenouscontainer is shown as an intravenous bag. The intravenous containercomprises an interior surface and an exterior surface. The interiorsurface includes a network of sensors configured to communicate with andprovide data to the robotic device.

FIG. 20 is a front view of the intravenous container of FIG. 19 wherethe network of sensors are disposed on an exterior surface of thecontainer.

FIG. 21 is a front view of the intravenous container of FIG. 19 wherethe network of sensors are disposed within the interior surface and theexterior surface of the container.

FIG. 22 is a perspective view of the robotic device of FIG. 2. The atleast one sensor of the intravenous container is communicating with therobotic device so that the robotic arm replaces the intravenouscontainer when it is empty.

FIG. 23 is a front view of an intravenous pump comprising at least onesensor configured to communicate with the robotic device.

FIG. 24 is a perspective view of the intravenous assembly and therobotic arm of FIG. 4. The robotic arm is shown silencing an errantsignal from being emitted by the intravenous pump of FIG. 23.

FIG. 25 is a block diagram of a system in which the robotic device isused to monitor and maintain the intravenous assembly, as well ascollect, transfer, process, and store data obtained from the sensors.

FIG. 26 is a block diagram of the system that monitors informationassociated with the intravenous assembly, the system comprising therobotic device including the optical and pressure sensors, the roboticarm coupled to the robotic device, a processing device and a powersupply.

FIG. 27 is a flow chart illustrating the logic executed by the systemwhen errant flow is detected by the sensors of the intravenous assembly.Information is monitored using one or more sensors in the intravenousassembly and the sensors of the robotic device, and the monitoredinformation is optionally processed by the processor. The optionallyprocessed information is transferred external to the robotic device andthe transferred information is received by one or more devices externalto the robotic device. The received information is processed by one ormore devices external to the robotic device. Information received isthen compared with errant parameters. A query of whether an errantparameter has been exceeded is prompted. If the errant parameter isexceeded, then commands are issued for the robotic device to correct theproblem associated with the errant parameter. If the errant parameter isnot exceeded, then the processed information is stored external to therobotic device for future access.

FIG. 28 is a flowchart of the logic executed by the robotic device whenprompted to change an intravenous container when it is empty.Information is monitored using one or more sensors of the intravenouscontainer, and the monitored information is optionally processed andtransferred. The transferred information is received by the roboticdevice and the received information is processed. Information receivedis then compared with errant parameters associated with an emptyintravenous container. A query of whether an errant parameter has beenexceeded is prompted. If the errant parameter has been exceeded, thencommands are issued for the robotic device to replace the emptyintravenous container with a new full intravenous container. If theerrant parameter is not exceeded, then a command is issued to “go backto start” to start over.

FIG. 29 is a flowchart illustrating logic steps associated with therobotic device when an alarm is generated by the intravenous pump. Analarm is generated by the intravenous pump. The robotic device detectsthe alarm through a sensor such as an optical or a sound sensor.Commands are issued by the processor for the robotic device to move itsarm and hand which are moved by the controller to turn the alarm off.The robotic device moves and contacts the intravenous pump and turns thealarm off. A command is then issued for an alert to be sent to medicalstaff and the alert is then sent alerting the medical staff that thealarm has been successfully turned off. A command is then issued to “goback to start”.

It is to be understood that the figures are not drawn to scale. Further,the relation between objects in a figure may not be to scale, and may infact have a reverse relationship as to size. The figures are intended tobring understanding and clarity to the structure of each object shown,and thus, some features may be exaggerated in order to illustrate aspecific feature of a structure.

Reference will now be made in detail to certain embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. While the invention will be described in conjunction with theillustrated embodiments, it will be understood that they are notintended to limit the invention to those embodiments. On the contrary,the invention is intended to cover all alternatives, modifications, andequivalents, which may be included within the invention as defined bythe appended claims.

The headings below are not meant to limit the disclosure in any way;embodiments under anyone heading may be used in conjunction withembodiments under any other heading.

DETAILED DESCRIPTION

The present disclosure may be understood more readily by reference tothe following detailed description of the disclosure presented inconnection with the accompanying drawings, which together form a part ofthis disclosure. It is to be understood that this disclosure is notlimited to the specific devices, methods, conditions or parametersdescribed and/or shown herein, and that the terminology used herein isfor the purpose of describing particular embodiments by way of exampleonly and is not intended to be limiting of the claimed disclosure. Thefollowing description is presented to enable any person skilled in theart to make and use the present disclosure.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of the application are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. Any numerical value, however, inherently contains certainerrors necessarily resulting from the standard deviation found in theirrespective testing measurements. Moreover, all ranges disclosed hereinare to be understood to encompass any and all subranges subsumedtherein. For example, a range of “1 to 10” includes any and allsubranges between (and including) the minimum value of 1 and the maximumvalue of 10, that is, any and all subranges having a minimum value ofequal to or greater than 1 and a maximum value of equal to or less than10, e.g., 5.5 to 10.

Definitions

With regard to the following description, it is to be understood bythose skilled in the art that unless a specific number of an introducedclaim element is recited in the claim, such claim element is not limitedto a certain number. For example, introduction of a claim element usingthe indefinite article “a” or “an” does not limit the claim to “one” ofthe element. Still further, the following appended claims can containusage of the introductory phrases “at least one” and “one or more” tointroduce claim elements. Such phrases are not considered to imply thatthe introduction of a claim element by the indefinite articles “a” or“an” limits any particular claim containing such introduced claimelement to coverage of devices or processes containing only one suchelement or containing more than one such element, even when the sameclaim includes the introductory phrases “one or more” or “at least one.”

It is to be further understood that claim terminology relating toelements A, B, and C recited as “one of A, B, and C” is intended tocover systems, devices or processes having one or more of element A, orone or more of element B, or one or more of element C, and does notrequire the presence of three of such elements A, B, and C, nor excludecoverage of systems, devices or processes including the presence ofthree of such elements A, B, and C. Likewise, recitation of “at leastone of A, B, and C” is to be given the same interpretation. On the otherhand, if it is intended to limit coverage of a claim to systems, devicesor processes including one of each of a set of elements, the phraseology“one of each of A, B, and C” or “at least one of each of A, B, and C” isused.

Ranges may be expressed herein as from “about” or “approximately” oneparticular value and/or to “about” or “approximately” another particularvalue. When such a range is expressed, another embodiment includes fromthe one particular value and/or to the other particular value.

For the purposes of this specification and appended claims, unlessotherwise indicated, all numbers expressing quantities of ingredients,percentages or proportions of materials, and other numerical values usedin the specification and claims, are to be understood as being modifiedin all instances by the term “about.” Accordingly, unless indicated tothe contrary, the numerical parameters set forth in the followingspecification and attached claims are approximations that may varydepending upon the desired properties sought to be obtained by theembodiments of the present disclosure. At the very least, and not as anattempt to limit the application of the doctrine of equivalents to thescope of the claims, each numerical parameter should at least beconstrued in light of the number of reported significant digits and byapplying ordinary rounding techniques.

Spatially relative terms such as “under”, “below”, “lower”, “over”,“upper”, and the like, are used for ease of description to explain thepositioning of one element relative to a second element. These terms areintended to encompass different orientations of the device in additionto different orientations than those depicted in the figures. Further,terms such as “first”, “second”, or the like, are also used to describevarious elements, regions, sections, etc. and are also not intended tobe limiting. Like terms refer to like elements throughout thedescription.

As used herein, the terms “having”, “containing”, “including”,“comprising” and the like are open ended terms that indicate thepresence of stated elements or features, but do not preclude additionalelements or features.

As used herein, the terms “having,” “containing,” “including,”“comprising,” and the like are open ended terms that indicate thepresence of stated elements or features, but do not preclude additionalelements or features.

It is also to be further understood that the doctrine of claimdifferentiation is to be applied across an independent claim and itsdependents and is not intended to be applied across a plurality ofindependent claims. For example, term A in a first independent claim maybe interpreted to have the same scope as term B in second independentclaim, while if term A is in a first independent claim and term Bfurther defines term A in claim dependent from the first independentclaim, then term A must have a broader scope than term B. In otherwords, phrases that differ from one independent claim to anotherindependent claim, may be interpreted to have equal scope and read oncommon structure yet present the structure using different terminologyin order account for differing interpretation of phrase language.

The term “robotic arm” refers to a device that is typically made up ofseven metal segments, joined by six joints. A computer can control therobot by rotating individual step motors which move in exact incrementsconnected to each joint which allows the computer to move the roboticarm very precisely, repeating exactly the same movement over and overagain if needed. In some embodiments, a robot or robot arms isconfigured to include motion sensors to facilitate accurate movement ofthe robotic arm.

The term “end effector” refers to the actively driven portion of therobotic arm such as the hand.

The term “autonomously” or “autonomous” refers to the ability of arobotic device and/or a robotic arm to have the ability to operateindependently and not be controlled by outside forces, such as, forexample humans.

The term “errant flow” refers to flow conditions that deviate fromnormal which are caused for example by high pressure or low pressure,air bubbles, occlusions, clots, and/or kinks in an intravenous assemblysuch as intravenous tubing.

The term “intravenous fluid” includes, but is not limited to 9% normalsaline, Lactated Ringers, 5% Dextrose in water, 4.5% normal saline, andcan include medicaments.

The term “medicament” or “medication” includes any substance (i.e.,compound or composition of matter) which, when administered to anorganism (human or animal) induces a desired pharmacologic and/orphysiologic effect by local and/or systemic action. The term thereforeencompasses substances traditionally regarded as actives, drugs orbioactive agents, as well as biopharmaceuticals typically employed totreat a number of conditions which is defined broadly to encompassdiseases, disorders, infections, or the like. The medicament can beadministered through intravenous administration, and can include, but isnot limited to chemotherapy drugs such as doxorubicin, vincristine,cisplatin, and paclitaxel; antibiotics such as vancomycin, oxacillin,ampicillin, levofloxacin, cefazolin, meropenem, or gentamicin;antifungal drugs such as micafungin and amphotericin; pain medicationssuch as hydromorphone and morphine; drugs for low blood pressure such asdopamine, epinephrine, norepinephrine, and dobutamine; andimmunoglobulin medications (IVIG).

Reference will now be made in detail to various embodiments of thepresent disclosure, examples of which are illustrated in theaccompanying drawings. While the embodiments of the present disclosurewill be described in conjunction with the illustrated embodiments, itwill be understood that they are not intended to limit the disclosure tothose embodiments. On the contrary, the disclosure is intended to coverall alternatives, modifications, and equivalents, which may be includedwithin the disclosure as defined by the appended claims.

The headings below are not meant to limit the disclosure in any way;embodiments under any one heading may be used in conjunction withembodiments under any other heading.

System

A system 30 is provided, as shown in FIGS. 1-24 that monitors andmaintains an intravenous assembly 32 autonomously or independently frommedical staff and can prevent alarms from the intravenous assembly frombeing triggered. The system includes a robotic device 34. The roboticdevice can be a full length or humanoid robot, as shown in FIGS. 1 and3, can be a single robotic arm 36, as shown in FIGS. 2 and 4 and/or canbe two robotic arms, as shown in FIG. 5. The robotic device can besimilar to the robot described in U.S. Pat. No. 10,300,597 assigned toSeiko Epson Corporation, incorporated herein by reference. The roboticdevice includes an optical sensor 38 that detects an errant flow in atleast a component of the intravenous assembly and a pressure sensor 40to manipulate at least the component of the intravenous assembly torestore, start, stop flow, or change at least the component of theintravenous assembly.

As will be described in more detail below, the intravenous assemblyincludes components such as an intravenous catheter 42, as shown inFIGS. 14-18, an intravenous tubing 44, as shown in FIGS. 8-9, anintravenous container 46, as shown in FIGS. 19-21 and/or an intravenouspump 48, as shown in FIGS. 23-24. The robotic arm of the robotic deviceis configured to engage at least one of the intravenous assemblycomponents when an errant flow is detected by the optical sensor so thatthe robotic device can monitor and maintain the intravenous assembly.The robotic device can also prevent or silence an errant signal or alarmemitted by the intravenous assembly. The errant flow detected in acomponent of the intravenous assembly can be caused by high pressure orlow pressure, air bubbles, occlusions, clots, and/or kinks in theintravenous tubing, catheter and/or the intravenous container.

The robotic arm can be made of for example, seven metal segments, joinedby six joints. A processor, as described below, can control the roboticarm by rotating individual step motors (not shown) which move in exactincrements connected to each joint which allows the processor to movethe robotic arm very precisely, repeating the same movement if needed. Apower supply can be coupled to the arm so that the arm can operatewithout being plugged into an electrical socket. The arm can be attachedto a component of the intravenous assembly such as on the intravenouspump and/or the intravenous tubing, as shown in FIGS. 6 and 10 orattached to an intravenous pole or stand 49, as shown in FIGS. 2 and 7.It is contemplated that the robotic arm can also be added to existingintravenous assemblies.

The robotic arm can include an end effector, such as a robotic hand 50.The robotic hand can assist the robotic device in monitoring andmaintaining the components of the intravenous assembly. For example, therobotic hand can be used to manipulate components of the intravenousassembly to correct issues found in the intravenous assembly by therobotic device. The robotic hand can include the pressure sensor. It iscontemplated that the robotic arm and/or the hand can alternatively bemanually operated by a user, such as medical staff. It is alsocontemplated that the end effector can include alternatives to a robotichand such as a probe, a hook or even medical tools such as a syringe. Itis to be understood that additional motors separate from the motors inthe robotic arm described above are used to articulate or actuate thehand.

As described above, the robotic device includes a processor 52 thatreceives and processes input from the optical and pressure sensors and acontroller 54 that is operatively connected to the processor andconfigured to operate the robotic device to manipulate at least one ofthe intravenous assembly components at least in part, on input from theoptical and pressure sensors and processed by the processor to restore,start, stop flow, or change at least the component of the intravenousassembly.

Each of the intravenous assembly components can include at least onesensor 56 to communicate with and provide data to the robotic device.The at least one sensor can include, but is not limited to an opticalsensor, a pressure sensor, a piezoelectrical sensor, an oxygen sensor, acarbon dioxide sensor, a nitrous oxide sensor, an upstream or downstreamocclusion sensor, an ultrasound sensor, a sonar sensor and/or a lasersensor. The robotic device can further include a motion sensor, apiezoelectrical sensor, an ultrasound sensor, a sonar sensor and/or alaser sensor.

The optical and pressure sensors of the robotic device and the at leastone sensor of a component of the intravenous assembly are capable oftransmitting and receiving data through a wireless connection, such as aBluetooth® radio wireless connection. For example, the robotic devicecan include a Bluetooth® radio 58 that is configured to pair with aBluetooth® radio 60 of a component of the intravenous assembly, as shownin FIG. 1. Further, activities performed by the robotic device, alarmsand maintenance of the intravenous assembly can be wireles sly and/orsilently communicated to a medical station or medical staff.

As described above, the intravenous assembly includes intravenous tubing44, as shown in FIGS. 8-9. The intravenous tubing extends from aproximal end 62 to a distal end 64 and includes the at least one sensor56 that is configured to communicate with and provide data to therobotic device. The at least one sensor can include, but is not limitedto a pressure sensor, a piezoelectric sensor, an oxygen sensor, a carbondioxide sensor, a nitrous oxide sensor and/or an upstream or downstreamocclusion sensor. The at least one sensor can be disposed at discretepositions on and/or within the intravenous tubing. For example, certainpositions on the tubing are considered problem areas such as locationsthat are highly manipulated by medical practitioners which include theproximal and distal ends of the tubing. The sensors can also be locatedat an end that is closest to the patient. As shown in FIG. 8, disposinga sensor at the proximal end and/or the distal end of the intravenoustubing will increase the likelihood that a sensor will accurately detecta cause of errant flow. Suitable intravenous tubing that can be used forexample in the intravenous assembly as described above includeintravenous tubing that is manufactured by Baxter (owned by BaxterHealthcare Corporation, an Illinois corporation).

The at least one sensor can also be a network of sensors that arelocated in continuous regions within an interior 66 and/or exterior wall68 of the intravenous tubing. For example, as shown in FIG. 9, thenetwork of sensors can be located along an entire length of the interiorand/or exterior wall of the intravenous tubing. The sensors can beembedded within the interior and/or exterior wall and/or can bemonolithically formed with the interior and exterior walls. The networkof sensors can include more than 1 to about 100 sensors. For example, anetwork of sensors can include 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25,30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 to about 100sensors.

The intravenous tubing may also include at least one valve, such as anoutlet valve 70 configured to facilitate release of air trapped withinthe interior of the intravenous tubing, as shown in FIG. 8. When the atleast one sensor detects air or gas bubbles within the intravenoustubing, the at least one sensor can communicate through the wirelessconnection or other electronic means to the robotic device so that thevalve can be opened to release the air or gas bubbles or to flush outthe bubbles from the tubing.

The valve can be opened and a syringe (not shown) or a laser (not shown)can be inserted into the valve by the robotic device so that air can beevacuated by the syringe or laser. The valve can also be used to laseror flush the intravenous tubing with saline to eliminate clots in thetubing. The valve can be opened by the robotic device, medical staff,and/or automatically. The valve can include a duckbill valve and/or aflap valve. The valve can be disposed at an end of the tubing ormultiple valves can be disposed along the length of the tubing.

The intravenous tubing may be made from a memory foam material. Thememory foam material can be manufactured from visco-elastic memory foam,but other foam materials may be used including foams made from silicon,various plastics, polyvinylchloride (PVC) and polyethylene. The memoryfoam material can have a varying elasticity depending on the desiredflexibility or stiffness of the tubing. Because of the properties of thememory foam material, the tubing will be able to unkink or untwistitself automatically.

The intravenous tubing can be macro intravenous tubing (10, 15, or 20gtts/min) and/or micro intravenous tubing (60 gtts/min). The intravenoustubing can include peripheral lines, central lines, midline catheterlines, continuous infusion lines, secondary IV, IV push, and/or volumeexpanders.

As shown in FIG. 10, the robotic hand is configured to engage theintravenous tubing to unkink or untwist the intravenous tubing. Theintravenous tubing can include attachment points 72 or a track disposedon the exterior wall of the tubing that facilitates movement of therobotic hand having corresponding attachments 73 that engage with theattachment points along the entire length of the tubing to unkink thetubing. The robotic arm or hand can include one or more laser sensors 74that form a laser perimeter P around the intravenous tubing. If asection of the intravenous tubing falls outside of the laser perimeter,then the robotic arm will be alerted and the robotic arm will unkink oruntwist the intravenous tubing.

Alternatively, when two robotic arms or hands are employed, as shown inFIGS. 3 and 11, the optical sensor and the pressure sensor of therobotic device can detect a kink or twist in the intravenous tubing andthe two robotic arms with hands will unkink or untwist the tubing. Therobotic device can also preemptively correct the intravenous tubingprior to when a kink or twist in the tubing fully develops when the atleast one sensor detects that the flow rate within the tubing hasdecreased.

As shown in FIGS. 12-13, the intravenous tubing can be disposed within asleeve 76. The sleeve includes a proximal end 78 and a distal end 80 andincludes at least one sensor 56 configured to communicate with andprovide data to the robotic device. As shown in FIG. 12, the at leastone sensor can be disposed on the proximal end and/or the distal end ofthe sleeve on an exterior surface 82 and/or on an interior surface 84.As shown in FIG. 13, the sleeve can include a network of sensorsdisposed along an entire length of the sleeve. The sleeve can beemployed with the intravenous tubing when the tubing does not includesensors or even if the tubing does include sensors. The sleeve can alsobe reusable.

The sleeve can have a thickness from about 1 millimeter (mm) to about 10mm, from about 1 mm to about 8 mm, from about 1 mm to about 6 mm, orfrom about 1 mm to about 4 mm. The thickness of the sleeve can also varydepending on the location. For example, the thickness of the sleeve canbe greater in areas along the length of the sleeve that do not containsensors and less thick in areas that contain a sensor.

The intravenous assembly includes catheter 42, as shown in FIGS. 14-18.The catheter extends from a first end 86 to a second end 88. At thefirst end, a needle 90 is provided that is configured for disposalwithin an entrance of a patient's blood vessel and is configured forinsertion into the blood vessel of the patient. The catheter includes atleast one sensor 56 disposed within an interior 92 and/or exterior 94 ofthe catheter, and is configured to communicate with and provide data tothe robotic device.

As shown in FIG. 14, the at least one sensor can be disposed at an endof the needle. The at least one sensor can also be disposed within or ona hub 96 of the catheter, as shown in FIG. 15. The at least one sensorcan be a network of sensors, and a sensor can be located on the end ofthe needle as well as within the hub of the catheter. The network ofsensors can also be disposed throughout the entire length of thecatheter. The at least one sensor can include a pressure sensor, apiezoelectric sensor, an oxygen sensor, a carbon dioxide sensor, anitrous oxide sensor and/or an upstream or downstream occlusion sensor.

As shown in FIGS. 16 and 17, the robotic hand is configured to engage anold catheter (FIG. 17) to remove and/or insert a new catheter (FIG. 18)into a patient. To assist in inserting a new catheter, the roboticdevice can include and/or can be coupled with ultrasound guidance or aDoppler attachment. By implementing the robotic device to insert a newcatheter into the patient, the amount of air bubbles in the catheter andthe intravenous tubing will decrease or be prevented from forming.

FIGS. 19-22 illustrate the intravenous container 46 of the intravenousassembly. The intravenous container can be a clear plastic bag or aglass container and includes an interior surface 98 and an exteriorsurface 100. The interior surface and/or the exterior surface caninclude at least one sensor 56 configured to communicate with andprovide data to the robotic device. The at least one sensor can includea pressure sensor, an oxygen sensor, a carbon dioxide sensor, a nitrousoxide sensor, an ultrasonic sensor, a piezoelectric sensor, anelectromagnetic sensor, an inductive or capacitive sensor, and/or anupstream or downstream occlusion sensor.

As shown in FIG. 19, the at least one sensor can include a network ofsensors disposed continuously throughout the interior surface of theintravenous container. Alternatively, a network of sensors can bedisposed on the exterior surface of the intravenous container, as shownin FIG. 20, or a network of sensors can be disposed on both the interiorsurface and exterior surface of the intravenous container, as shown inFIG. 21. Additionally, a sensor can be located within a port 102 of theintravenous container, as shown in FIG. 19.

The at least one sensor of the intravenous container is configured tocommunicate with at least one sensor of a second intravenous containerand the robotic device to replace the intravenous container with thesecond intravenous container when the intravenous bag is empty or nearlyempty, as shown in FIG. 22. The second intravenous container can bealerted to start infusing fluid once the original intravenous containeris empty or nearly empty so that a continuous and seamless infusion canoccur. Valves or tubing attached to each of the containers can alsocontain sensors and be in communication with each other so that thevalve in the original container closes as the other valve of the secondcontainer opens for infusion. The at least one sensor is also capable ofcommunicating with the robotic device alone to replace the intravenouscontainer when it is empty. The intravenous containers and the roboticdevice can communicate through the Bluetooth® wireless connectiondescribed above or through other electronic means. By implementing therobotic device to replace the old intravenous bag with a new one, theamount of air bubbles that would form from replacement of theintravenous bag manually will decrease or be prevented.

The intravenous container can include a flow sensor and/or a volumesensor. The flow and/or volume sensor can provide data on the amount offluid remaining in the intravenous container so that the robotic deviceknows when to remove and/or replace the intravenous container.

In addition to sensors being used to detect errant flow in thecomponents of the intravenous assembly, a handheld spectrophotometer canalso be used by the robotic device and/or the medical staff to detect ifthere is precipitation and/or a clot in the intravenous tubing and/orthe intravenous container. For example, handheld spectrophotometers thatcan be used in conjunction with this system are manufactured by TruScan™(owned by Thermo Scientific™, a Delaware corporation).

FIG. 23 illustrates the intravenous pump 48 of the intravenous assembly.The intravenous pump includes at least one sensor configured tocommunicate with and provide data to the robotic device. The at leastone sensor can include a pressure sensor, an oxygen sensor, a carbondioxide sensor, a nitrous oxide sensor, an optical sensor, apiezoelectrical sensor, an upstream or downstream occlusion sensor, anultrasound sensor, a sonar sensor and/or a laser sensor. Similar to theother components of the intravenous assembly described above, the atleast one sensor of the pump can be a network of sensors.

As shown in FIG. 24, the robotic device can engage and interact with theinfusion pump with the robotic arm and hand. For example, the roboticdevice can prevent or silence an errant signal or alarm emitted by theintravenous pump by directly interfacing with buttons 104 and/or ascreen 106 of the pump.

The intravenous pump can include various types of pumps including, butnot limited to a large volume pump, a patient controlled pump, aninsulin pump, an elastomeric pump, an enteral pump, a syringe pump, anambulatory pump, and a stationary infusion pump. Additionally, theinfusion pump may also be may be applied to intra-arterial infusion.Suitable intravenous pumps that can be used for example in theintravenous assembly as described above include pumps that aremanufactured by Baxter (owned by Baxter Healthcare Corporation, anIllinois corporation).

It is contemplated that the pump can be wirelessly charged to eliminatethe need for plugging the pump into an electrical socket. Wirelesscharging would prevent a low battery and a low battery alarm signal frombeing triggered. A wireless charger can be placed in every patient roomat a hospital or medical facility. The pump can alternatively beequipped with a battery that is larger than a standard sized batterythat is typically included with an intravenous pump.

The at least one sensor can alternatively be detachable from componentsof the intravenous assembly described above. For example, the at leastone sensor can be attached to the exterior surface or exterior wall ofcomponents of the intravenous assembly by adhesive, adhesive strips,Velcro®, clips, hooks, magnets, snaps, buttons, interference fittings,friction fittings, compressive fittings, posts, connectors, and/orfixation plates. It will be understood, that although the at least onesensor is shown as a circular shape, other shapes are contemplated suchas, rectangular, crescent, oval, square, hexagonal, pentagonal, and/ortriangular.

The robotic device can include indicia, such as LEDs 108 located on anexterior surface of the robotic device, as shown in FIG. 3. The LEDs canindicate when the robotic device is monitoring, maintaining andcorrecting components of the intravenous assembly. The indicia can beone or more LED lights used as visual indicators. The LEDs can bevarious colors, such as, for example, blue, red, yellow, white, green,purple, pink and/or orange to visually indicate to medical staff whatcomponent of the intravenous assembly is being maintained or corrected.

The robotic device can include a display 110, as shown in FIG. 3, on anexterior surface that displays indicia to indicate to medical staff or apatient what component of the intravenous assembly is being maintainedor corrected. The display can include device(s) such as 412 liquidcrystals display (LCD), flat panel, or a solid state display. It iscontemplated that the robotic device can also include a speaker and/or aremote control.

The robotic device may also include an imaging unit such as an imagesensor or camera including CMOS (complementary metal-oxidesemiconductor) and CCD (charge-coupled device) which can aid indetermining coordinates associated with a patient's blood vessel whendisposing a catheter into a patient with the robotic device. It iscontemplated that a laser rangefinder which uses a laser beam todetermine the distance to an object can also be used in connection withthe robotic device.

The system may also include or be coupled to an imaging modality such asultrasound, CT, fluoroscopy or MRI, overhead 3D stereotactic system (viapre-procedure MRI and/or CT). For example, imaging devices useful incoupling with the system described herein comprise without limitationMagnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging(fMRI), Magnetic Resonance Spectroscopy (MRS), diffusion MRI (DWI),diffusion tensor MRI (DTI), electroencephalography (EEG),magnetoencephalography (MEG), nuclear neuroimaging, positron emissiontomography (PET), single photon emission computed tomography (SPECT),Ictal-Interictal SPECT Analysis by Statistical Parametric Mapping(ISAS), Computed Tomography (CT), x-ray, fluoroscopy, angiography,ultrasonography, transcranial magnetic stimulation (TMS), transcranialdirect current stimulation (tDCS), transcranial electrical stimulation(TES), motor evoked potential (MEP), somatosensory evoked potential(SSEP), phase reversal of somatosensory evoked potential, evokedpotential, electrocorticography (ECoG), direct cortical electricalstimulation (DCES), microelectrode recording (MER) or local fieldpotential recording (LFP).

As described above, the system including the robotic device, the sensorsof the robotic device, components of the intravenous assembly and theircorresponding sensors can communicate through a wireless connection suchas a Bluetooth® radio. The Bluetooth® radio of the robotic device canpair with the Bluetooth® radio of the component of the intravenousassembly so that data can be transmitted. It is contemplated that inaddition to the robotic device and components of the intravenousassembly having a wireless connection such as a Bluetooth® radio, apersonal computer used by the medical staff can also include a wirelessconnection so that the system can communicate to the personal computer.Examples of a personal computer include, but is not limited tonetwork/stand-alone computers, personal digital assistants (PDAs), WebTV(or other Internet-only) terminals, set-top boxes, cellular/phones,screenphones, pagers, blackberry, smart phones, iPhone, iPad, table,peer/non-peer technologies, kiosks, or other known (wired or wireless)communication devices, etc.

The system can further include a software program that is associatedwith operation of the robotic device and/or a software programassociated with a message digest with a date and time stamp that liststhe various tasks performed by the robotic device on the components ofthe intravenous assembly. In some embodiments, information compiled fromthe message digest can be transmitted via Wi-Fi to a web dashboard onmedical staff computers. The web dashboard can generate a report for themedical staff.

Dedicated hardware implementations, such as but not limited to ASICs(Application Specific Integrated Circuits), programmable logic arrays,and other hardware devices can likewise be constructed to implement thesystem described herein. Applications that include the system of variousembodiments broadly comprise a variety of electronic and computersystems. Some embodiments implement functions in two or more specificinterconnected hardware modules or devices with related control and datasignals communicated between and through the modules, or as portions ofan ASIC. Thus, the example system is applicable to software, firmware,and/or hardware implementations.

Data from the sensors of the components of the intravenous assembly maybe downloaded in one or more textual/graphical formats (e.g., RTF, PDF,TIFF, JPEG, STL, XML, XDFL, TXT etc.), or set for alternative deliveryto a smartphone and/or the web dashboard of a computer employed bymedical staff.

The medical staff can interface with the computer (e.g., smartphone, acomputer of the practitioner etc.) via a user interface that may includeone or more display devices (e.g., CRT, LCD, or other known displays) orother output devices (e.g., printer, etc.), and one or more inputdevices (e.g., keyboard, mouse, stylus, touch screen interface, or otherknown input mechanisms) for facilitating interaction of the medicalstaff with the data from the sensors via the user interface. The userinterface may be directly coupled to a database or directly coupled to anetwork server system via the Internet or cloud computing.

In some embodiments, the user interface device may be implemented as agraphical user interface (GUI) containing a display or the like, or maybe a link to other user input/output devices known in the art.Individual or of a plurality of devices (e.g., network/stand-alonecomputers, personal digital assistants (PDAs), WebTV (or otherInternet-only) terminals, set-top boxes, cellular/phones, screenphones,pagers, blackberry, smart phones, iPhone, iPad, table, peer/non-peertechnologies, kiosks, or other known (wired or wireless) communicationdevices, etc.) may similarly be used to execute one or more computerprograms (e.g., universal Internet browser programs, dedicated interfaceprograms, etc.) to allow medical staff to interface with the sensor datain the manner described. Database hardware and software can be developedfor access by medical staff through personal computers, mainframes, andother processor-based devices. Medical staff may access the data storedlocally on hard drives, CD-ROMs, stored on network storage devicesthrough a local area network, or stored on remote database systemsthrough one or more disparate network paths (e.g., the Internet).

The electronic circuitry in the robotic device, may include some or allof the capabilities of a computer in communication with a network and/ordirectly with other computers. The computer may include the processor asdescribed above, a storage device, a display or other output device, aninput device, and a network interface device, all connected via a bus. Abattery can be provided to couple and power the computer. The computermay communicate with a network. The processor represents a centralprocessing unit of any type of architecture, such as a CISC (ComplexInstruction Set Computing), RISC (Reduced Instruction Set Computing),VLIW (Very Long Instruction Word), or a hybrid architecture, althoughany appropriate processor may be used. The processor executesinstructions and includes that portion of the computer that controls theoperation of the entire computer. The processor typically includes acontrol unit (the controller) that organizes data and program storage inmemory and transfers data and other information between the variousparts of the computer. The processor receives input data from the inputdevice (e.g., the at least one sensor) and the network reads and storesinstructions (for example processor executable code) and data in a mainmemory, such as random access memory (RAM), static memory, such as readonly memory (ROM), and a storage device. The processor may also presentdata to a user via an output device or user interface, as describedabove, such as the screen of the smartphone or the monitor of the webdashboard of the medical staff's computer or a display is the roboticdevice is equipped with one.

Data can be stored in storage devices or systems (e.g., Random AccessMemory (RAM), Read Only Memory (ROM), hard disk drive (HDD), floppydrive, zip drive, compact disk-ROM, DVD, bubble memory, flash drive,redundant array of independent disks (RAID), network accessible storage(NAS) systems, storage area network (SAN) systems, etc.), CAS (contentaddressed storage) may also be one or more memory devices embeddedwithin a CPU, or shared with one or more of the other components, andmay be deployed locally or remotely relative to one or more componentsinteracting with the memory or one or more modules. The database mayinclude a data storage device, a collection component for collectinginformation from users or other computers into centralized database, atracking component for tracking information received and entered, asearch component to search information in the database or otherdatabases, a receiving component to receive a specific query from a userinterface, and an accessing component to access centralized database. Areceiving component is programmed for receiving a specific query fromone of a plurality of users. The database may also include a processingcomponent for searching and processing received queries against datastorage device containing a variety of information collected by thecollection device.

The disclosed system may be associated with a computer network-basedsystem. The computer network may take any wired/wireless form of knownconnective technology (e.g., corporate or individual LAN, enterpriseWAN, intranet, Internet, Virtual Private Network (VPN), combinations ofnetwork systems, etc.) to allow a server to provide local/remoteinformation and control data to/from other locations (e.g., other remotedatabase servers, remote databases, network servers/user interfaces,etc.). For example, a network server may be serving one or more usersover a collection of remote and disparate networks (e.g., Internet,intranet, VPN, cable, special high-speed ISDN lines, etc.). The networkmay comprise one or more interfaces (e.g., cards, adapters, ports) forreceiving data, transmitting data to other network devices, andforwarding received data to internal components of the system (e.g., theat least one sensor or network of sensors of the robotic device andcomponents of the intravenous assembly).

Components of the intravenous assembly, such as the sleeve used inconjunction with the intravenous tube, is reusable and washable. Thesystem and its components can be made from various materials, such as,for example, plastic, such as a thermoplastic material. In someembodiments, materials include, but are not limited to thermoplasticssuch as polyaryletherketone (PAEK) including polyetheretherketone(PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK),carbon-PEEK composites, PEEK-BaSO4 polymeric rubbers, polyethyleneterephthalate (PET), polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy and theircombinations.

The system and its components can also be made from materials such as,for example stainless steel alloys, aluminum, commercially puretitanium, titanium alloys, Grade 5 titanium, super-elastic titaniumalloys, cobalt-chrome alloys, superelastic metallic alloys (e.g.,Nitinol, super elasto-plastic metals, for example GUM METAL®), ceramicsand composites thereof for example calcium phosphate (e.g., SKELITE™),fabric, silicone, polyuret copolymers, polymeric rubbers, polyolefinrubbers, hydrogels, semi-rigid and rigid materials, elastomers.

The system and its components can also be made from materials such as,for example polyester (PES), polyethylene (PE), high-densitypolyethylene (HDPE), polyvinyl chloride (PVC), polyvinylidene chloride(PVDC) (Saran), low-density polyethylene (LDPE), polypropylene (PP),polystyrene (PS), high impact polystyrene (HIPS), polyamides (PA)(Nylons), acrylonitrile butadiene styrene (ABS),polyethylene/acrylonitrile butadiene styrene (PE/ABS), polycarbonate(PC), polycarbonate/acrylonitrile butadiene styrene (PC/ABS), and/orpolyurethanes (PU).

The system and its components, individually or collectively, may also befabricated from a heterogeneous material for example a combination oftwo or more of the above-described materials.

Components of the intravenous assembly such as the sleeve used inconjunction with the intravenous tubing can be sterilized by radiationvia terminal sterilization. Terminal sterilization of a product providesgreater assurance of sterility than from processes such as an asepticprocess, which requires individual product components to be sterilizedseparately and the final package assembled in a sterile environment.

Gamma radiation can also be used in the terminal sterilization step,which involves utilizing ionizing energy. Gamma rays are highlyeffective in killing microorganisms, they leave no residues, nor do theyhave sufficient energy to impart radioactivity to the spacer. Gamma rayscan be employed when the spacer is in a package and gamma sterilizationdoes not require high pressures or vacuum conditions, thus, packageseals and other components are not stressed. In addition, gammaradiation eliminates the need for permeable packaging materials.

Electron beam (e-beam) radiation may also be used to sterilize one ormore components of the intravenous assembly. E-beam radiation comprisesa form of ionizing energy, which is generally characterized by lowpenetration and high-dose rates. E-beam irradiation is similar to gammaprocessing in that it alters various chemical and molecular bonds oncontact, including the reproductive cells of microorganisms. Beamsproduced for e-beam sterilization are concentrated, highly-chargedstreams of electrons generated by the acceleration and conversion ofelectricity.

Robotic Device Operation

FIG. 25 is a block diagram of a system in which the robotic device isused to monitor and maintain the intravenous assembly, as well ascollect, transfer, process, and store data obtained from the sensors.The robotic device 34 can wirelessly transfer the data to, for example,a router 200, personal computer 202, phone 204, and/or any otherelectronic device capable of performing wireless transfers of theinformation. The router 200, personal computer 202, and/or phone 204 canthen further transfer this data to and/or from the router 200, personalcomputer 202, phone 204, and/or network 206 using wired and/or wirelesstechniques. This information may be further processed and/or stored viathe network 206 by using, for example, the personal computer 202, server208, and/or database 210. Each of the router 200, phone 204, personalcomputer 202, network 206 may include capability to receive and/ortransmit information from and/or to any other device using wired and/orwireless techniques and/or protocols, such as but not limited to,Bluetooth, Wi-Fi, radio frequency, optical, and/or any other type ofwireless communication linkage. The network 206 may be any type ofnetwork including, but not limited to, a wide area network, local areanetwork, and/or telephone network.

FIG. 26 is a block diagram of the system. The system can include therobotic device 34, the robotic arm 36, the processor or processingdevice 52, and a power supply 300 operatively coupled together usingunidirectional and/or bidirectional connections. The robotic device 34includes the optical and pressure sensors described above designed tomonitor errant flow through physical, chemical, biological, and/orenvironmental information associated with the intravenous assembly, andprovide this information to the processor 52 and/or robotic arm 36. Theprocessor 52 may perform further processing on the information obtainedfrom the robotic device 34, and provide the processed information to therobotic arm 36. The robotic device 34 is able to wirelessly transferdata between the robotic device 34 and devices external to the roboticdevice, such as the router 200, phone 204, and personal computer 202,and network 206 shown in FIG. 25. The power supply 300 provides power tothe robotic device, robotic arm 36, and processor 52.

The system may also include a computer-readable storage device (notshown) operatively coupled to at least one of the robotic device 34,processor 52, and/or robotic arm 36. The computer-readable storagedevice is configured to store data provided by the robotic device 34,robotic arm 36, and/or processor 52 for subsequent retrieval and/ortransmission. The computer-readable storage device may include, forexample, Flash memory, RAM, ROM, EEPROM, or any other computer-readablestorage medium which can be used to store information.

FIG. 27 is a flow chart illustrating the logic executed by the systemwhen errant flow is detected by the sensors of the intravenous assembly.Information is monitored using one or more sensors in the intravenousassembly (e.g., the intravenous tubing, intravenous catheter,intravenous container and/or intravenous pump) and the sensors of therobotic device such as the pressure sensor and the optical sensor instep 400, and the monitored information is optionally processed by theprocessor in step 402. The optionally processed information istransferred external to the robotic device by for example, a wirelessconnection in step 404, and the transferred information is received byone or more devices external to the robotic device in step 406. Thereceived information is processed by one or more devices external to therobotic device in step 408. Information received is then compared witherrant parameters associated with high pressure or low pressure, airbubbles, occlusions, clots, and/or kinks in an intravenous assembly suchas intravenous tubing in step 410. A query of whether an errantparameter has been exceeded in step 412 is prompted. If the errantparameter is exceeded, then commands are issued for the robotic deviceto correct the problem associated with the errant parameter in step 414.If the errant parameter is not exceeded, then the processed informationis stored external to the robotic device for future access in step 416.It is to be understood that the robotic device can correct the problemassociated with an errant parameter before an alarm is triggered in theintravenous pump.

FIG. 28 is a flow chart illustrating the logic executed by the roboticdevice when prompted to change an intravenous container that is empty.Information is monitored using one or more sensors of the intravenouscontainer in step 500, and the monitored information is optionallyprocessed and transferred in steps 502 and 504 respectively. Thetransferred information is received by the robotic device in step 506and the received information is processed in step 508. Informationreceived is then compared with errant parameters associated with anempty intravenous container in step 510. A query of whether an errantparameter has been exceeded in step 512 is prompted. If the errantparameter is exceeded, then commands are issued for the robotic deviceto replace the empty intravenous container with a new full intravenouscontainer in step 514. If the errant parameter is not exceeded, then acommand is issued to “go back to start” to start over in step 516.

FIG. 29 is a flowchart illustrating logic steps associated with therobotic device when an alarm is generated by the intravenous pump. Analarm is generated by the intravenous pump in step 600. The roboticdevice detects the alarm through a sensor such as an optical or a soundsensor in step 602. Commands are issued by the processor for the roboticdevice to move its arm and hand which are moved by the controller toturn the alarm off in step 604. The robotic device moves and contactsthe intravenous pump and turns the alarm off in step 606. A command isthen issued for an alert to be sent to medical staff in step 608 and thealert is then sent alerting the medical staff that the alarm has beensuccessfully turned off in step 610. A command is then issued to “goback to start” in step 612.

The term “processor” as used herein is intended to include anyprocessor, such as, for example, one that includes a CPU (centralprocessing unit) and/or other forms of processing circuitry. Further,the term “processor” may refer to more than one individual processor.

The term “memory” is intended to include memory associated with aprocessor or CPU, such as, for example, RAM (random access memory), ROM(read only memory), a fixed memory device (for example, hard drive), aremovable memory device (for example, diskette), a flash memory and thelike. In addition, the display device(s) 412, input device(s) 414,cursor control device(s) 416, signal generation device(s) 420, etc., canbe collectively referred to as an “input/output interface,” and isintended to include one or more mechanisms for inputting data to theprocessing device(s), and one or more mechanisms for providing resultsassociated with the processing device(s). Input/output or I/O devicesincluding but not limited to keyboards (e.g., alpha-numeric inputdevice(s), display device(s), and the like) can be coupled to the systemeither directly (such as via bus) or through intervening input/outputcontrollers (omitted for clarity).

In an integrated circuit implementation of one or more embodiments ofthe disclosure, multiple identical die are typically fabricated in arepeated pattern on a surface of a semiconductor wafer. Each such diemay include a device described herein, and may include other structuresand/or circuits. The individual dies are cut or diced from the wafer,then packaged as integrated circuits. One skilled in the art would knowhow to dice wafers and package die to produce integrated circuits. Anyof the exemplary circuits or method illustrated in the accompanyingfigures, or portions thereof, may be part of an integrated circuit.Integrated circuits so manufactured are considered part of thisspecification.

An integrated circuit in accordance with the embodiments of thedisclosed embodiments can be employed in essentially any applicationand/or electronic system in which buffers are utilized. Suitable systemsfor implementing one or more embodiments of the disclosed embodimentsinclude, but are not limited, to personal computers, interface devices(e.g., interface networks, high-speed memory interfaces (e.g., DDR3,DDR4), etc.), data storage systems (e.g., RAID system), data servers,etc. Systems incorporating such integrated circuits are considered partof the disclosed embodiments. Given the teachings provided herein, oneof ordinary skill in the art will be able to contemplate otherimplementations and applications.

In accordance with various embodiments, the methods, functions or logicdescribed herein are implemented as one or more software programsrunning on a computer processor. Dedicated hardware implementationsincluding, but not limited to, application specific integrated circuits,programmable logic arrays and other hardware devices can likewise beconstructed to implement the methods described herein. Further,alternative software implementations including, but not limited to,distributed processing or component/object distributed processing,parallel processing, or virtual machine processing can also beconstructed to implement the methods, functions or logic describedherein.

It should also be noted that software, which implements the methods,functions and/or logic herein, are optionally stored on a tangiblestorage medium, such as: a magnetic medium, such as a disk or tape; amagneto-optical or optical medium, such as a disk; or a solid statemedium, such as a memory card or other package that houses one or moreread-only (non-volatile) memories, random access memories, or otherre-writable (volatile) memories. A digital file attachment to e-mail orother self-contained information archive or set of archives isconsidered a distribution medium equivalent to a tangible storagemedium. Accordingly, the disclosure is considered to include a tangiblestorage medium or distribution medium as listed herein and otherequivalents and successor media, in which the software implementationsherein are stored.

Medicaments

Various medicaments (e.g., medications) can be administered through theintravenous assembly described above. For example, these medicamentsinclude, but are not limited to Abatacept, Acetaminophen, Acetazolamide,Acetylcysteine, Acyclovir, Adenosine, Albumin, Aldesleukin, Alemtuzumab,Alfentanil, Alphal-Proteinase Inhibitor, Alprostadil, Alteplase,Amikacin Sulfate, Aminocaproic Acid, Aminophylline, Amiodarone,Amobarbital, Amphotericin B, Amphotericin B Lipid Complex (Abelcet®),Amphotericin B Liposomal (AmBisome®), Ampicillin Sodium,Ampicillin/sulbactam (Unasyn®), Antihemophilic Factor, VI,Antihemophilic Factor IX, Recombinant, Antihemophilic Factor VIII,Monoclonal, Antihemophilic Factor VIII, Recombinant, Antithrombin III,Antivenin, Lactrodectus mactans, Aprotinin, Arginine, Arsenic Trioxide,Ascorbic Acid, Atracurium Besylate, Atropine Sulfate, Azathioprine,Azacitidine, Azithromycin, Aztreonam, Basiliximab, Belimumab,Bendamustine, Benztropine, Bevacizumab, Bivalirudin, Bleomycin Sulfate,Bortezomib, Bumetanide, Busulfan, Benzoate, Calcium Gluconate,Carboplatin, Carfilzomib, Carmustine, Cefotaxime, Ceftaroline,Ceftazidime, Ceftriaxone, Cefuroxime, Cetuximab, Chloramphenicol,Chlorothiazide, Cidofovir, Ciprofloxacin, Cisplatin, Cladribine,Clofarabine, Colistimethate, Cosyntropin, Cyclophosphamide,Cyclosporine, Cytarabine, Cytomegalovirus immune globulin, or acombination thereof.

The medicaments can also include, but are not limited to Dacarbazine,Daclizumab, Dactinomycin, Daptomycin, Daratumumab, Daunorubicin,Deferoxamine, Desmopressin, Dexamethasone, Dexmedetomidine, Dexrazoxane,Digoxin, Dihydroergotamine Mesylate, Docetaxel, Dopamine, Doxorubicin,Doxycycline, Droperidol, Edrophonium Chloride, Ephedrine, Ethacrynicacid, Etomidate, Etoposide, Fat Emulsion 20%, Fenoldopam, FentanylCitrate, Ferric Sodium Gluconate, Fluconazole, Fludarabine, Flumazenil,Fluorouracil, Folic Acid, Ganciclovir, Gemcitabine, Glucagon,Glucarpidase, Granisetron, Haloperidol Lactate, Heparin, Hydroxyzine,Immune Globulin (IVIG), Indigotindisulfonate Sodium, insulin, InterferonAlfa-2B, Ipilimumab, Irinotecan, Iron Dextran, Iron Sucrose,Isavuconazonium sulfate (isavuconazole), Isoproterenol, Ketamine,Ketorolac, Labetalol, Leucovorin Calcium, Levetiracetam, Levothyroxine,Lorazepam, Magnesium Sulfate, Mannitol, Mechlorethamine, Melphalan,Meperidine, Methadone, Methotrexate, Methylene Blue, Micafungin,Mitomycin, Morphine, Naloxone, Nitroglycerin, Norepinephrine,Obinutuzumab, Octreotide, Oxacillin, Oxytocin, Paclitaxel, Pamidronate,Papaverine, Pegaspargase, Penicillin G Potassium, Pentamidine,Pentostatin, Phenobarbital, Phenylephrine, Phosphate (Potassium),Phosphate (Sodium), Phytonadione(Vitamin K), Piperacillin/tazobactam,Potassium Acetate, Potassium Chloride, Potassium Phosphate, Propranolol,Pyridoxine, Quinidine Gluconate, Ranitidine, Remifentanil, Rho D ImmuneGlobulin, Rifampin, Sargramostim, Secretin, Sodium Acetate, SodiumBicarbonate, Sodium Chloride 1.8%, Sodium Chloride 3%, Sodium Phosphate,Tacrolimus, Telavancin, Thiamine, Tigecycline, Tobramycin, Tromethamine,Vancomycin, Verapamil, Zinc trace metal, Zidovudine, Zoledronic Acid ora combination thereof.

Intravenous fluids can also be administered by the intravenous assemblydescribed above. Intravenous fluids include, but are not limited todextrose solutions such as 2.5%, 5%, 20% and 50% dextrose, sodiumchloride solutions such as 5% NaCl (hypertonic), 3% NaCl (hypertonic),0.9% NaCl (isotonic), 0.45% NaCl (hypotonic), 0.2% NaCl (hypotonic),sodium chloride solutions with dextrose such as 2.5% dextrose/0.45% NaCl(hypotonic), 5% dextrose/0.9% NaCl (isotonic), 5% dextrose/0.45% NaCl(isotonic) 5% dextrose/0.9% NaCl (hypertonic), and multiple electrolytesolutions such as Ringers solution, Lactated Ringer's, Normosol R andPlasma-Lyte M that are either isotonic, hypotonic or hypertonicsolutions.

The illustrations of embodiments of the disclosure described herein areintended to provide a general understanding of the structure of variousembodiments, and they are not intended to serve as a completedescription of all the elements and features of devices and systems thatmight make use of the structures described herein. Many otherembodiments will become apparent to those skilled in the art given theteachings herein; other embodiments are utilized and derived therefrom,such that structural and logical substitutions and changes can be madewithout departing from the scope of this disclosure. The drawings arealso merely representational and are not drawn to scale. Accordingly,the specification and drawings are to be regarded in an illustrativerather than a restrictive sense.

Embodiments are referred to herein, individually and/or collectively, bythe terms “embodiment,” “may include,” “can include” or “it iscontemplated” merely for convenience and without intending to limit thescope of this application to any single embodiment or concept if morethan one is, in fact, shown. Thus, although specific embodiments havebeen illustrated and described herein, it should be understood that anarrangement achieving the same purpose can be substituted for thespecific embodiment(s) shown; that is, this disclosure is intended tocover any and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will become apparent to those of skill inthe art given the teachings herein.

In the foregoing description of the embodiments, various features aregrouped together in a single embodiment for the purpose of streamliningthe disclosure. This method of disclosure is not to be interpreted asreflecting that the claimed embodiments have more features than areexpressly recited in each claim. Rather, as the following claimsreflect, disclosed subject matter lies in less than all features of asingle embodiment. Thus, the following claims are hereby incorporatedinto the Detailed Description, with each claim standing on its own as aseparate example embodiment.

Given the teachings of the disclosure provided herein, one of ordinaryskill in the art will be able to contemplate other implementations andapplications of the techniques of the disclosure. Although illustrativeembodiments of the disclosure have been described herein with referenceto the accompanying drawings, it is to be understood that the disclosureis not limited to those precise embodiments, and that various otherchanges and modifications are made therein by one skilled in the artwithout departing from the scope of the appended claims.

While particular embodiments of the present disclosure have been shownand described, it will be appreciated by those skilled in the art that,based upon the teachings herein, changes and modifications may be madewithout departing from this disclosure and its broader aspects and,therefore, the appended claims are to encompass within their scope allsuch changes and modifications as are within the true spirit and scopeof this disclosure.

Applications to Covid-19 Disease Diagnosis

According to a further aspect of this disclosure, the robotic device isconfigured to facilitate diagnosis of conditions indicating potential oractual Covid-19 disease. With reference to FIG. 4, for example, in thisaspect the effector is positioned around the tubing (or even thepatient's finger) to facilitate a type of pulse-oximetry measurement. Inthis embodiment element 38 is a light source (e.g., a pair of lightemitting diodes (LEDs)), and element 40 is a photodetector (e.g., aphotodiode). For example, one LED is red with a wavelength of 660nanometers, while the other LED is infrared with a wavelength of 940nanometers. Oxygenated hemoglobin absorbs more infrared light and allowsmore red light to pass through, whereas deoxygenated hemoglobin allowsmore infrared light to pass through and absorbs more red light. Inoperation, the LEDs are sequenced, and the photodiode receives thetransmitted light. Using known signal processing (provided by theprocessor) based on the ratio of the red light measurement to theinfrared light measurement, the oximeter determines the percentage ofblood that is loaded with oxygen. Upon an indication of an oxygendeficiency or anomaly as measured by the oximeter, a notification (e.g.,an alert) is provided to medical staff or other interested persons(including the patient). in this manner, the robot is used to indirectlymonitor oxygen saturation in the patient's blood, thereby providing anaccurate and safe indication of an underlying condition indicative ofpotential Covid-19 disease.

In an alternative embodiment, the robot arm that carries appropriatesensors and detectors is commanded into position, e.g., to grasp afinger of a patient, and controlled using those sensors and detectors(and associated processor support and software) to noninvasively detectmolecules indicative of the SARS-Cov-2 virus or its antibodies. Thus,and once again with reference to FIG. 4, element 38 is aninterferometer. One example would be a bimodal waveguide interferometer,which is a device that uses two modes of a light beam traveling in asingle waveguide. Element 40 is a photodetector, which records theinterference between the light modes as the light passes through thebodily fluid. By processing the signals generating by the photodetector,relevant molecules (or their absence) is detected. The biosensor resultsare then output to medical staff or other interested persons orentities.

Biosensors carried by the robot are not limited to those that use light.Every protein or molecule has its unique electrical charge, lightabsorption, and magnetic force. Depending on the nature of the testing,the biosensor can also be one that detects unique electrical charge, ormagnetic force, or combinations of any of the above.

The true spirit and scope is considered to encompass devices andprocesses, unless specifically limited to distinguish from known subjectmatter, which provide equivalent functions as required for interactionwith other elements of the claims and the scope is not consideredlimited to devices and functions currently in existence where futuredevelopments may supplant usage of currently available devices andprocesses yet provide the functioning required for interaction withother claim elements. Furthermore, it is to be understood that thedisclosure is solely defined by the appended claims.

1-9. (canceled)
 10. A system to monitor and autonomously configured an intravascular assembly without medical staff involvement or presence, the intravascular assembly having tubing through which fluids are delivered intravenously, comprising: a robotic device having an end effector, and at least one sensor that continuously monitors the tubing; and a control subsystem (a) responsive to detection by the at least one sensor of an errant flow through the tubing that results from one of: a kink or twist in the tubing, an air bubble in the tubing, an occlusion or clot in the tubing, and pressure variations; (b) to generate a command that controls the end effector to initiate engagement with and mechanical manipulation of the tubing to remediate the errant flow; wherein the end effector manipulates the tubing in advance of an audible alarm being generated in association with the intravascular assembly.
 11. The system as described in claim 10 wherein the end effector also includes a light source that issues a coherent light beam along a length of the tubing, and wherein the sensor is an optical sensor that senses movement a portion of the tubing that breaks the coherent beam.
 12. The system as described in claim 10 further including: a positioning subsystem comprising one or more physical structures positioned adjacent the tubing.
 13. The system as described in claim 12 wherein the mechanical manipulation includes moving the end effector along the one or more physical structures to unkink or untwist the tubing.
 14. The system as described in claim 10 wherein the control subsystem is further configured to control the intravascular assembly to deactivate an alarm indication associated with the intravascular assembly.
 15. An apparatus, comprising: an intravascular assembly having tubing through which fluids are delivered intravenously; a robotic device having an end effector, and at least one sensor that continuously monitors the tubing; and a control device comprising hardware and associated software configured (a) responsive to detection by the at least one sensor of an errant flow through the tubing that results from one of: a kink or twist in the tubing, an air bubble in the tubing, an occlusion or clot in the tubing, and pressure variations; (b) to generate a command that controls the end effector to initiate engagement with and mechanical manipulation of the tubing to remediate the errant flow; wherein the end effector manipulates the tubing in advance of an audible alarm being generated in association with the intravascular assembly.
 16. The apparatus as described in claim 15 wherein the end effector also includes a light source that issues a coherent light beam along a length of the tubing, and wherein the sensor is an optical sensor that senses movement a portion of the tubing that breaks the coherent beam.
 17. The apparatus as described in claim 16 further including: one or more physical structures positioned adjacent the tubing, wherein the mechanical manipulation includes moving the end effector along the one or more physical structures to unkink or untwist the tubing.
 18. The apparatus as described in claim 15 wherein the control device is further configured to control the intravascular assembly to deactivate an alarm indication associated with the intravascular assembly. 19-20. (canceled) 